FDA to Harmonize COVID-19 Data with New Terminology Codes
May 13, 2020In a bid to standardize the reporting of diagnostic test results and improve data gathering and analysis, the US Food and Drug Administration said it plans to develop new terminology codes.
The agency described a program to develop the new codes on Wednesday during its fifth weekly town hall meetings with SARS-CoV-2 diagnostic developers.
The codes to be developed could draw from several initiatives already completed or underway to harmonize diagnostic data reporting. FDA’s Center for Devices and Radiological Health has standardized diagnostics terminology that it encourages manufacturers to use in the submission process. On its website, FDA also refers to Clinical Data Interchange Standards Consortium (CDISC). This standards developing organization announced a task force to create guidance on standardizing COVID-19 research data last month, which it noted the FDA was aware of and observing. CDISC also recently made interim COVID-19-specific terminology available.